Medical mystery, deaths bring RU-486 under scrutiny

November 30, 2005|By Bonita Brewer, Knight Ridder Newspapers

LIVERMORE, Calif. — The rare bacteria that caused the massive infection that killed 18-year-old Holly Patterson of Livermore in 2003 has now been linked to all four California women who died after taking the RU-486 abortion pill.

The recent finding has led the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention to plan a scientific meeting to discuss what many view as a medical mystery, FDA spokeswoman Julie Zawisza confirmed.

"We will further explore the issues and outstanding questions we don't have answers to right now," she said. "We don't know whether or not there's any link [to the RU-486]. We're trying to better understand this organism itself and its toxicity, what it does and under what conditions."

The bacteria determined to have caused deadly infection in two of the California cases, including Patterson's, was identified in July as Clostridium sordellii, and was under investigation in the other two. But the FDA in a public health advisory this month said all four cases have now been linked to the Clostridium sordellii bacteria.

According to the FDA, the bacterial infection can lead to weakness, nausea, vomiting and diarrhea but can lack some usual symptoms of infection, including fever.

Because the four cases were clustered in California (Patterson's was the only one in the Bay Area) a study was done to determine if the abortion pills distributed in California somehow became contaminated with Clostridium sordellii.

But that was found not to be the case, the FDA update said.

"This is very significant," said Monty Patterson, Holly's father, noting that a woman who died in Canada after taking RU-486 during clinical trials in 2001 also suffered a Clostridium sordellii infection. "Here's a so-called extremely rare bacteria that's so lethal there is no known cure for it"--at least once infection has flourished--"that's caused five of the five reported deaths."

Patterson says RU-486 should be pulled from U.S. markets. He noted some researchers believe the abortion pill itself impairs the immune system and makes patients more vulnerable to infection with Clostridium sordellii, an organism that occurs naturally in some women.

One such researcher, Dr. James McGregor of the University of Southern California, discussed that theory this year in two medical publications.

FDA officials in July said the rate of infection leading to death among women using RU-486 is comparable to the rate for women giving birth or undergoing surgical abortion--about 1 in 100,000 cases.

FDA guidelines say RU-486 should be given in the first seven weeks of pregnancy and call for its follow-up drug, misoprostol, to be given orally during a second office visit. But many doctors, on the basis of published studies, prescribe misoprostol in higher doses to be inserted vaginally at home.

The FDA says it has not been determined that such "off-label" use is responsible for the deaths.

For now, "There's been no causal relationship established that links the deaths to the drug itself," said Pamela Long, a spokeswoman for Danco Laboratories, which manufactures RU-486. She said she has not yet been officially informed of the planned meeting between the FDA and CDC.